Effect of Low Molecular Heparin on Pregnancy Outcome With Protein S Deficiency

Summary

To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.

Conditions

• Pregnancy Related
• Protein S Deficiency

Interventions

DRUG

Enoxaparin

Enoxaparin 4000 IU/day by subcutaneous injection at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis.

DRUG

Aspirin

Aspirin 75mg, orally, once daily at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis.

DRUG

Enoxaparin

Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.

Sponsors & Collaborators

• Beijing Obstetrics and Gynecology Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Peking Union Medical College Hospital

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Sichuan Academy of Medical Sciences

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Beijing Chuiyangliu Hospital

  collaborator OTHER_GOV

• Peking University People's Hospital

  lead OTHER

Principal Investigators

• Xiao-Hui Zhang, Professor · Peking University Insititute of Hematology, Peking University People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• China

Study Locations